Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
46489–46512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 2011
SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM
K112025 · KWP
Spinal USA
Orthopedic · 62d
Cleared Sep 15, 2011
VITEK 2 STRPTOCOCCUS AMPICILLIN
K112075 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Sep 15, 2011
SILICONE SPHERES
K112176 · HPZ
Oculo Plastik, Inc.
Ophthalmic · 49d
Cleared Sep 15, 2011
QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION...
K112360 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 29d
Cleared Sep 15, 2011
4CH FLEX SPEEDER
K112366 · MOS
Toshiba Medical Systems Coporation,...
Radiology · 29d
Cleared Sep 15, 2011
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
K112372 · DSP
Cardiac Assist, Maquet...
Cardiovascular · 29d
Cleared Sep 15, 2011
TRAGET DETACHABLE COIL
K112385 · HCG
Stryker Neurovascular
Neurology · 28d
Cleared Sep 14, 2011
LITE PELVIC FLOOR REPAIR KITS
K103426 · OTP
Boston Scientific Corp
Obstetrics & Gynecology · 296d
Cleared Sep 14, 2011
COLLAGEN POWDER
K103648 · KGN
Innocoll Pharmaceuticals, Ltd.
General & Plastic Surgery · 274d
Cleared Sep 14, 2011
KJ SUBMERGED SYSTEM
K103810 · DZE
Kj Meditech Co., Ltd.
Dental · 259d
Cleared Sep 14, 2011
FOB ONE STEP RAPID TEST
K110309 · KHE
Orient Gene Biotech
Hematology · 224d
Cleared Sep 14, 2011
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD
K111322 · JXM
Chemtron Biotech, Inc.
Toxicology · 126d
Cleared Sep 14, 2011
SHEAUMANN PL-980
K111360 · GEX
Sheaumann Lasers
General & Plastic Surgery · 121d
Cleared Sep 14, 2011
DIGITAL RETINAL CAMERA
K111612 · HKI
Canon, Inc.
Ophthalmic · 97d
Cleared Sep 14, 2011
THE INSYNC CERAMIC SYSTEM
K111743 · EIH
Jensen Industries, Inc.
Dental · 85d
Cleared Sep 14, 2011
PADLOCK
K111814 · DYH
Reliance Orthodontic Products, Inc.
Dental · 79d
Cleared Sep 14, 2011
ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
K111996 · JJY
Elitechgroup
Chemistry · 63d
Cleared Sep 14, 2011
ELECSYS MYOGLOBIN CALCHECK 5
K112113 · JJX
Roche Diagnostics
Chemistry · 51d
Cleared Sep 14, 2011
OCTOTMPORT
K112196 · OTJ
Dalim Surgnet Corporation
General & Plastic Surgery · 44d
Cleared Sep 14, 2011
EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K112198 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 44d
Cleared Sep 14, 2011
VITAL SIGNS MONITOR
K112465 · DQA
Advanced Instruments, Inc.
Anesthesiology · 19d
Cleared Sep 13, 2011
EPISIL
K101769 · OLR
Camurus AB
General & Plastic Surgery · 446d
Cleared Sep 13, 2011
SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104
K102483 · CAH
Sunset Healthcare Solutions, LLC
General Hospital · 379d
Cleared Sep 13, 2011
COLGATE DESENSITIZING DENTAL CREAM
K103461 · LBH
Colgate-Palmolive Co.
Dental · 293d